ReiThera Srl, a biotech company dedicated to the technology development, GMP manufacturing and clinical translation of genetic vaccines and medicinal products for advanced therapies, and Exothera, a full-service contract development and manufacturing organization (CDMO), have entered into a collaboration agreement to develop a large-scale, low cost per dose manufacturing process for the production of ReiThera’s novel vaccines.

The collaboration will be financed by a €3 million grant awarded by the Bill & Melinda Gates Foundation to develop and deliver new low-cost vaccines based on ReiThera’s GRAd technology platform, including against COVID-19 and HIV, mostly for Low- and Middle-Income countries (LMIC) in Africa. Immunization remains one of the most impactful and cost-effective public health interventions in Low and Middle-Income countries who are still struggling to secure access to adequate supplies.

The scale-up manufacturing process will leverage Exothera’s expertise using the NevoLi-ne Upstream platform (integrating the intensified structured fixed-bed scale-X nitro bioreactor), developed by Exothera’s sister company, Univercells Technologies. This innovative biomanufacturing technology has a highly compact footprint while delivering unmatched cost-effective vaccine production.

Under the terms of the agreement, Exothera will scale up the proprietary cell line into the NevoLine and infect them with GRAd vector to create the bulk vaccine product, which ReiThera will then purify. The viral bulk generated after the infection will be purified by a high performing process developed by ReiThera.

ReiThera will start with its GRAd vector currently used in its COVID-19 vaccine candidate (GRAd-COV2) for the initial process development set-up and transition it into final form for further clinical trial purposes in its state-of-the-art GMP manufacturing facility.

“This collaboration with Exothera is an important step in providing ReiThera’s novel vaccines for further study in a range of serious diseases, and in particular for seeking a solution that makes these vaccines more readily available once approved to people in LMIC regions,” said Stefano Colloca, chief technology officer and co-founder, ReiThera. “This second Bill & Melinda Gates Foundation grant, following an initial grant to ReiThera in November 2021 to support the development of the GRAd platform, provides further validation of ReiThera’s innovative technology and underscores our technical expertise in clinical manufacturing and bio-risk management.”

José Castillo, chairman, Exothera, said, “ReiThera’s innovative GRAd platform technology paired with Exothera’s process development and scaling-up know-how has the potential to make important vaccines available for all. Combining our process know-how with Univercells Technologies’ Nevoline will provide Low- and Middle-Income countries with access to much needed solutions for unmet medical needs such as HIV as well as against the current global pandemic.”